Anatabloc sales voluntarily suspended in dispute with FDA

The former Virginia company that makes the controversial nutritional supplement Anatabloc is voluntarily suspending its sales while trying to resolve a regulatory dispute with the Food and Drug Administration.

Anatabloc is made by Sarasota, Fla., -based Rock Creek Pharmaceuticals, formerly known as Star Scientific Inc. and based in Glen Allen.

The company’s founder and former CEO, Jonnie Williams Sr., is the star witness in the corruption trial of former Gov. Bob McDonnell and his wife Maureen.

Federal prosecutors have accused the McDonnells of helping Williams promote Anatabloc in exchange for more than $165,000 in gifts and loans.

Anatabloc is Rock Creek’s primary product. In a news release announcing the company’s second-quarter earnings, the company said it was suspending sales of Anatabloc and CigRx, another product, while it awaits action from the FDA.

The FDA sent the company a warning letter in December to stop making therapeutic claims about Anatabloc and CigRx. The agency said the company had promoted the supplements in a way that made them unapproved new drugs under federal law.

In a statement released Monday, Rock Creek said it had filed a document with the FDA called a New Dietary Ingredient Notification (NDIN) in June to address issues raised in the warning letter.

“Although the company does not believe that an NDIN is a prerequisite to the lawful marketing of the nutritional supplement, the NDIN was voluntarily submitted to provide the FDA with preclinical and clinical data concerning the supplement,” the company said.

Rock Creek said it was suspending sale of the two products “until such time as the company can complete its review of the FDA's response to the company's pending NDIN, which has not yet been received, as well as a review of how the nutritional supplement business may affect the company's drug development program. However, the company does anticipate that these actions will bring the FDA warning letter matter to a close."

In its earnings report, the company said it had net sales of $700,000 for the second quarter, down 71 percent from the same period last year. The company said the drop was caused by decreased promotion and marketing expenses “associated with the administrative status of Anatabloc during the period."

The company reported a net loss $12.7 million for the second quarter compared with a loss of $8.7 million in the second quarter of 2013.